18 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sysmex UF-5000 Fully Automated Urine Particle Analyzer
FDA 510(k)
FDA Class 2
·Hematology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704294279·
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659485617·Steinmann pin 3 Shank End, Diamond Point_x000D_...
Steinmann pin 3 Shank End, Diamond Point 2.4mm/229mm, Sutur Passer
FDA UDI
mahe medical gmbh·EMAHKM718830·Steinmann pin 3 Shank End, Diamond Point
2.4mm/...
IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
6F ENGAGE/ENGAGE TR INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
EON MINI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 7, 2013
ARCHITECT I2000SR ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·July 22, 2011
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code JTC·July 9, 2008
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·July 15, 2024
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·June 29, 2020
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·June 14, 2024
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·August 19, 2021
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·May 15, 2023
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·February 14, 2023
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 7, 2023
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·January 27, 2022
Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM, SYNTEL RT-EMB; A4408, 7F-80CM, SYNTEL RT-EMB; A4F00, 2F-60CM (PREM) SYNTEL CATHETER; A4F01, 2F-80CM, (PREM) SYNTEL CATHETER; A4F02, 3F-40CM, (PREM) SYNTEL CATHETER; A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; A4F04, 4F-40CM, (PREM) SYNTEL CATHETER; A4F05, 4F-80CM, (PREM) SYNTEL CATHETER; A4F06, 5F-80CM, (PREM) SYNTEL CATHETER; A4F07, 6F-80CM, (PREM) SYNTEL CATHETER; A4F08, 7F-80CM, (PREM) SYNTEL CATHETER; CE0260ST, L2F-60CM PREM SYNTEL CATH; CE0280ST, L2F-80CM PREM SYNTEL CATH; CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER; CE0380ST, 3F-80CM PREM SYNTEL CATH; CE0440ST, 4F-40CM PREM SYNTEL CATH; CE0480ST, 4F-80CM PREM SYNTEL CATH; CE0580ST, 5F-80CM PREM SYNTEL CATH; CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER; CE0780ST, 7F-80CM PREM SYNTEL CATH; CE0340, 3F-40cm, SYNTEL RT-EMB; CE0380, 3F-80cm, SYNTEL RT-EMB; CE0440, 4F-40cm, SYNTEL RT-EMB; CE0480, 4F-80cm, SYNTEL RT-EMB; CE0580, 5F-80cm, SYNTEL RT-EMB; CE0680, 6F-80cm, SYNTEL RT-EMB; CE0780, 7F-80cm SYNTEL RT-EMB. BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·October 3, 2012